Adverse Events Module

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Adverse Events Module

For researchers submitting trial data to ClinicalTrials.gov, the Adverse Events module is one of four mandatory results sections. It requires reporting in three primary categories: All-Cause Mortality: A table tracking all deaths that occurred during the study, regardless of cause. Serious Adverse Events (SAEs): A tabular summary of events resulting in death, life-threatening conditions, hospitalization, or significant disability. Other Adverse Events: A table for non-serious events that exceed a specific frequency threshold, such as 5% within any study arm.

Adverse Events Module path is as follows:

Study -> Results Section -> Adverse Events Module -> Event Groups

Study -> Results Section -> Adverse Events Module -> Serious Events

Study -> Results Section -> Adverse Events Module -> Other Events

Adverse Events Module

Ignite Creation Date: 2025-12-25 @ 1:14 AM
Ignite Modification Date: 2025-12-25 @ 11:24 PM
NCT ID: NCT01298193
Description: This section includes related and no related Adverse Events and Serious Adverse Events. There are not adverse events related to aprepitant treatment in cycle 2.
Frequency Threshold: 0
Time Frame: Through study treatment, average of 6 weeks
Study: NCT01298193
Study Brief: Incidence of Chemotherapy-Induced Nausea and Vomiting Associated With Docetaxel-Cyclophosphamide in Early Breast Cancer.
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Observational Phase (First Cycle): Day 0 (Dexamethasone 8mg) Day 1 (5-HT3 antagonist, Ondansetron: 8 mg x2, Granisetron: 1mg x2,Tropisetron: 5 mg, Dexamethasone 24 mg). • Chemotherapy: Docetaxel 75mg/m2 and Cyclophosphamide 600mg/m2 Days 2 and 3 (Dexamethasone 16 mg). 1 None 31 185 47 185 View
Efficacy Phase (Second Cycle): Day 0 (Dexamethasone 8mg) Day 1 (Aprepitant: 125 mg,5-HT3 antagonist, Ondansetron: 8 mg x2, Granisetron: 1mg x2, Tropisetron: 5 mg, Dexamethasone 12 mg). Chemotherapy: Docetaxel 75mg/m2 and Cyclophosphamide 600mg/m2 Days 2 and 3 (Aprepitant: 1 capsule of 80 mg daily, Dexamethasone 8 mg). 0 None 0 24 22 24 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Anemic Shock SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders NCI CTC version 4.0 View
Febrile Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders NCI CTC version 4.0 View
Pulmonary embolism SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders NCI CTC version 4.0 View
Colon Diverticulitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders NCI CTC version 4.0 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders NCI CTC version 4.0 View
Febrile Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders NCI CTC version 4.0 View
Febrile neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders NCI CTC version 4.0 View
Lower Gastrointestinal Bleeding SYSTEMATIC_ASSESSMENT Gastrointestinal disorders NCI CTC version 4.0 View
Mucositis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders NCI CTC version 4.0 View
Erythema with pruritus and skin lessions SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders NCI CTC version 4.0 View
Enterocollitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders NCI CTC version 4.0 View
Neutrophil Count Decreased SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders NCI CTC version 4.0 View
Neutrophil Count Decreased SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders NCI CTC version 4.0 View
Neutrophil Count Decreased SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders NCI CTC version 4.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders NCI CTC version 4.0 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders NCI CTC version 4.0 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders NCI CTC version 4.0 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders NCI CTC version 4.0 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders NCI CTC version 4.0 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders NCI CTC version 4.0 View